inforMED
MalfunctionFLE

ATLAS

Received Feb 6, 2025 · Event occurred Jan 7, 2025

Report 3005899764-2025-00010 · MDR key 21326667

Device

Generic name

20" Atlas Transfer Carriage

Model number

FV020002

Catalog number

FV020002

Product problems

  • Mechanical Problem
  • Mechanical Problem

Patient

NA · Unknown

  • Bruise/Contusion
  • Bruise/Contusion

Narrative

Description of Event or Problem

THE USER FACILITY REPORTED THAT AN EMPLOYEE INJURED THEIR FINGER WHILE UNLOADING THEIR 20" ATLAS TRANSFER CARRIAGE FROM THEIR STERILIZER. THE EMPLOYEE WENT TO THE EMERGENCY ROOM; HOWEVER, IT IS UNKNOWN IF ANY MEDICAL TREATMENT WAS RECEIVED.

Additional Manufacturer Narrative

A STERIS SERVICE TECHNICIAN ARRIVED ONSITE TO INSPECT THE ATLAS TRANSFER CARRIAGE. DURING THE TECHNICIAN'S INSPECTION HE FOUND THAT SCREWS WERE MISSING ON THE FRONT LATCH THAT LOCK INTO THE STERILIZER'S CHAMBER. AS THE FRONT LATCH DID NOT OPERATE PROPERLY, THIS CAUSED THE TRANSFER CARRAIGE TO BECOME UNSTABLE SUBSEQUENTLY CAUSING THE REPORTED EVENT TO OCCUR. THE TECHNICIAN REPAIRED THE TRANSFER CARRIAGE, TESTED THE FUNCTION AND OPERATION OF THE DEVICE AND RETURNED IT TO SERVICE. NO ADDITIONAL ISSUES HAVE BEEN REPORTED. THE TRANSFER CARRIAGE IS NOT UNDER A STERIS SERVICE CONTRACT FOR MAINTENANCE ACTIVITIES; THE USER FACILITY IS RESPONSIBLE FOR ALL MAINTENANCE ACTIVITIES.